Institutional change and political
decision-making in the creation of the Brazilian National
Health Surveillance Agency
Mudança institucional e processo de decisão
política: a criação da Agência Nacional de
Vigilância Sanitária
1 Agência Nacional de Saúde Suplementar, Ministério da Saúde, Rio de Janeiro, Brasil. 2 Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
Correspondence M. F. Piovesan Agência Nacional de Saúde Suplementar, Ministério da Saúde. Av. Augusto Severo 84, Rio de Janeiro, RJ 20021-040, Brasil
marcia.piovesan@ensp.fiocruz.br
Márcia Franke Piovesan 1 Maria Eliana Labra 2
Abstract
This article examines the decision-making pro-cess that led to the creation of the Brazilian Na-tional Health Surveillance Agency (ANVISA) in 1999. The authors begin by discussing the his-tory of the Agency’s predecessor, the Health Sur-veillance Secretariat, and the need for its mod-ernization to adjust the quality of the products under its control to domestic and international demands. From the theoretical perspective of neo-institutionalism, the article goes on to ana-lyze the social and political context surround-ing the debate on the proposed alternatives to adjust Health Surveillance to new rules in line with such requirements, focusing especially on the formulation of the new policy, the decision-making arena, and the actors with specific inter-ests in the sector. The research drew on extensive documentary and media material, plus inter-views with key actors. The article concludes that a determinant factor for the creation of ANVISA was the favorable domestic political context, fos-tering a positive correlation of forces that (in an extremely short timeframe, 1998-1999) allowed the creation of the first regulatory agency in the social policies area in Brazil.
Health Surveillance; National Health Surveil-lance Agency; Public Policies
Introduction
The aim of this article is to analyze the political/ institutional context that gave rise to the Brazil-ian National Health Surveillance Agency (Agên-cia Nacional de Vigiân(Agên-cia Sanitária – ANVISA) in the 1990s, especially 1998 and 1999, when the final decisions were made and the respective leg-islation was enacted.
A brief history of the Federal level of Health Surveillance in Brazil shows that it was inevita-bly characterized by technical and political gaps and impediments, which constrained its action over time and refueled the claims of its purported inoperability. Blatant problems resulted from its inaction at many stages in this historical process, reverberating in the mass media and causing public outcry, with no responses that might have tended to set rules for the power game, i.e., policy institutionalization and a corresponding search for solutions.
Against this backdrop, the point of departure for our research was the following question: what were the factors or events that influenced the de-cision to solve such a longstanding problem, in the form of a public policy drafted and approved in such an usually short timeframe?
public policy results. By shaping the stakehold-ers’ strategies and goals, mediating their relations of conflict and cooperation, and leading the de-cision-making processes along given pathways, the institutional rules provide the structure for political situations, allowing choices or inducing constraints at different moments in the decision-making process.
By focusing on institutions as both a prod-uct and conditioning factor for political conflicts and choices, while constraining and shaping the stakeholders’ strategies and behaviors, it is pos-sible to understand the central issues in political life: choice and constraint 2,3,4.
Social actors involved in the political power struggle create institutions, and understanding them requires analyzing the incentives, oppor-tunities, and constraints that emerge for the vari-ous actors in this dispute 2,3. The historical analy-sis of these processes is one of the central points in the neo-institutionalist approach, whose hard core is found in institutions with standardized relations, in which interactions between rules, stakeholders, interests, strategies, and power are identified and integrated in a given context, al-lowing to capture the complexity of real political situations 4,5,6.
Drawing on primary sources, we sought to specifically unveil the interactions of conflict and cooperation between the actors, their strate-gies for influencing decisions, and the rules of the game conditioning the alternatives for action by the Executive and Legislative Branches.
We have divided our presentation into three parts: (1) a brief background on Health Surveil-lance at the Federal level in Brazil from the 19th century to 1999; (2) aspects pertaining to the for-mer Health Surveillance Secretariat from 1990 to 1998; and (3) the political decision to create ANVISA in the 1998-1999 political context. We conclude with key observations on how this in-stitution was created and its enormous relevance for the protection of the Brazilian population’s health.
Political/institutional evolution in Health
Surveillance at the Federal level in
Brazil: a synthesis
Health Surveillance today can be viewed as an in-tegrated set of legal, technical, inspection, infor-mation, education, and research actions aimed at exercising health-related control over activi-ties, services, and the production and consump-tion chain entailing potential risk to health and the environment, thereby protecting and pro-moting the population’s health 7,8,9. Historically,
in Brazil this vast range of actions and interven-tions belonged to the public health sphere, under the responsibility of the Ministry of Health since its creation in 1953. Health Surveillance is cur-rently part of the Unified National Health System (Sistema Único de Saúde – SUS) and is respon-sible for the health-related control of medicines, food, beverages, tobacco products, hygiene prod-ucts and perfumes, cleaning prodprod-ucts, medical, dental, and hospital equipment and materials, immunobiologicals, blood and blood products, human organs and tissues for use in transplan-tation, radioisotopes and radioactive drugs, and products involving any risk to health and ob-tained through genetic engineering. It also ex-ercises health control over health services, ports, airports, and border stations, physical installa-tions, equipment, technologies, environments, and processes involved in the production phases of these goods and products, and the destination of waste and the transportation and distribution of the above-mentioned products 10.
Measures aimed at the inspection and con-trol of the health environment in Brazil date far back in Brazil’s history. It is beyond the scope of this article to describe the full historical evolu-tion, however based on research by various au-thors 1,7,8,9,11,12,13, Table 1 summarizes the most important political/institutional facts marking the history of Health Surveillance at the Federal level, from the country’s Imperial period until the creation of ANVISA in 1999.
The intricate pathway of health control poli-cies in Brazil shaped a profuse normative mosaic that expressed the political, health, and econom-ic concerns of each given period in the country’s history, with ups and downs and an effectiveness that fell short of its growing industrial and so-cial complexity. Measures in response to isolated problems, lack of coordination among health measures, and lack of homogeneity and scope in government action at the national level, along with absence of specificity according to regional diversity, demonstrated the lack of an effective National Health Surveillance Policy. Such charac-teristics can be explained primarily by the histor-ical weakness of the Brazilian state’s roles in rela-tion to public health. Even after the Ministry of Health was created its responsibilities remained extremely modest, given that it was confined to the most traditional and backward sector of the public administration, with scant funding and minimum political power to intervene.
Table 1
Summary of the most relevant political and institutional facts in the history of Health Surveillance at the Federal level in Brazil (19th and 20th centuries).
Period Phases of government Institutional facts
1808-1889 Empire • Health control in ports as the main concern
• 1810; Purveyor’s Regiment: medical police model
• 1820; Public Health Inspector’s Office, Rio de Janeiro Port Authority. Other public health services:
municipal until 1849
• 1885; Imperial Health Services Reform: land and maritime health services. Superior Public Health
Board: normative functions
1889-1930 First Republic • 1891 Constitution. Ministry of Justice and Internal Affairs. Public Health: units created with
normative, advisory, and executive functions.
• Compulsory notification of transmissible diseases: yellow fever, cholera, plague, diphtheria, scarlet
fever, measles
• 1890; Public Health Board and Office of the Inspector-General for Hygiene
• 1892; Public Health Laboratories (São Paulo)
• 1893; Port Authority Health Service of the Republic. Office of the Inspector of Port Health
• 1894; Federal Health Institute (Rio de Janeiro)
• 1897; Office of the Director-General of Public Health. Organization of hygiene services • 1902; Compulsory notification of contagious diseases, subject to the Penal Code
• 1903-1908; Oswaldo Cruz: Office of the Director-General of Public Health. Mission: eliminate yellow
fever and plague. Draining and sanitation, city center, Rio de Janeiro
• 1904; Mandatory vaccination against smallpox. Reorganization of Hygiene Services
• 1920; National Department of Public Health
• 1920-1926; Carlos Chagas Reform
• 1923; Federal Health Regulations incorporate the term Health Surveillance: health control of diseased individuals (or those suspected of transmissible diseases) and public establishments
and locations
1930-1945 Vargas Government • 1937; Ministry of Education and Health. Definition of the fields of action of Health Surveillance. Health control unified under the Port Health Service. Incorporation of recommendations by
international health agreements
1946-1963 Democratic Republic • 1953; Ministry of Health
• 1954; Central Laboratory for the Control of Drugs and Medicines (LCCDM)
• 1961; National Public Health Code
• Central Laboratory for the Control of Drugs, Medicines, and Food (LCCDMA)
1964-1982 Military Regime and • Decree 200/67 ascribes responsibility to the Ministry of Health for formulating and coordinating Democratic Transition the National Health Policy
• Health Surveillance: health control of ports and borders, extended in the 1970s to products
and services
• 1976-1977; National Health Surveillance Secretariat (SNVS)
• LCCDMA transferred to the Oswaldo Cruz Foundation. In 1981, transformed into the National
Institute for Quality Control in Health (INCQS)
• Important health control legislation enacted, still in force (Acts 5,991/73, 6,360/76, and 6,437/77
and Decree-Act 986/69)
1985-1994 New Republic; • 1986; National Conference on Consumers’ Health
José Sarney, Fernando • 1988 Federal Constitution establishes the universal right to health Collor, and Itamar Franco • 1990; Unified National Health System (SUS) (Acts. 8,080/90 and 8,142/90) Administrations • Consumer Defense Code (Act 8,078/90)
• 1992; Name of SNVS changed to Health Surveillance Secretariat (SVS)
• 1993; Incorporation of the National Institute for Medical Care and Social Security (INAMPS) into
the Ministry of Health
• 1994; Ministry of Health Ruling MS/GM 1,565/94 establishes guidelines for the National Health
Surveillance System (SNVS)
1995-1999 Fernando Henrique • 1999; National Health Surveillance Agency (Act 9,782/99)
Cardoso Administration
Médica da Previdência Social – INAMPS) into the Ministry of Health in 1993, which brought crucial changes to the field of public health, to the extent that unprecedented power resources were added to the renewed Ministry. Based on this strength-ened position and changes in the field of political forces, in 1995 new directions materialized for the Health Surveillance Secretariat. These factors, combined with the international dissemination of new ideas on the increased state regulatory role, expressed in Brazil in the Program for Public Sector Administrative Reform 14, as well as the requirements of international trade agreements, were crucial to the drafting of a new Health Sur-veillance agenda.
The 1990s scenario
The 1990s began with the opening of Brazil to im-ports in step with a radical deregulation of crite-ria for granting registration of products subject to Health Surveillance under the Ministry of Health project called Inovar (Innovate) 8,13. According to Federal Deregulation Program guidelines 15 re-lated to state intervention in the market, the basic principles of Inovar were the restriction of govern-ment interference in companies and the creation of a product quality assurance system. While the first principle was expressed in the granting of product registration with no prior technical re-view, especially for medicines 8,13, the second was never implemented. Revoked in 1993 on grounds that it was detrimental to the public health, the project aggravated the existing disorder in the Federal sphere of Health Surveillance 13.
A series of events, including various exposés of administrative improbity, administrative turn-over, partisan political interference in naming in-dividuals to various administrative positions, and pressure to grant product registration character-ized the scenario in 1994, bringing to public light the chaotic situation of the Health Surveillance Secretariat. Newspaper stories (Folha de S. Paulo
database, 1990-2000) featured suspicions con-cerning corruption, in addition to complaints by successive administrators who charged precari-ous funding, impediments to action, and politi-cal interference in decisions. However, no explicit clashes were noted between public and private agents, perhaps because both sides appeared to reap benefits from the corrosion of the Health Surveillance Secretariat.
In the mid-1990s, pork-barrel political trad-eoffs, nepotism, and low technical capacity permeated the Health Surveillance Secretariat. Meanwhile, there was a significant expansion in Brazil’s industrial and social complexity,
interna-tional trade, pressure by economic blocks, and international trade competition. Problems relat-ed to inefficient health control thus multiplirelat-ed.
Within this context, the “colonization” of the Health Surveillance Secretariat by private and partisan political interests began to bother the various interests. The industrial sector, which had always benefited from the inoperability of health control, now needed its agility and bless-ing to compete on the international market, giv-en that quality adds value to a marketed product. Meanwhile, the Federal government, which had invariably sought to keep health control from in-terfering with the economic logic of those who backed its political projects, needed to project an image of institutional reliability and stability to bolster its image on the international market. In addition, since the new international trade rules required that government acts be predictable, it was crucial for the country to look trustworthy and secure to investors. Such premises are basic for understanding the period from 1995 to 1998, marked at the domestic level by efforts towards economic stabilization and institutional gover-nance.
This period witnessed the expansion of inter-actions between players from the Health Surveil-lance Secretariat’s field of activity, including the Ministries of Finance and Foreign Relations, and especially between the Chamber of Foreign Com-merce and Itamaraty (Foreign Relations), due to the prevalence of agreements signed within the sphere of the Southern Cone Common Market (MERCOSUL), especially for the harmonization of normative health control acts.
Transforming the Health Surveillance Sec-retariat became the object of numerous dis-cussions. Unsuccessful attempts were made by Health Minister Adib Jatene (1995-1996), includ-ing the pursuit of financial autonomy through cooperative agreements with international fund-ing agencies, increased product registration tax-es, and the formation of a task force to turn the Health Surveillance Secretariat into an autono-mous body with regulatory capacity in keeping with international standards.
In 1995-1996, both Minister Jatene and Health Surveillance Secretary Elisaldo Carlini (1995-1997) were politically focused on creating the Federal Health Surveillance Agency (Agên-cia Federal de Vigilân(Agên-cia Sanitária – AGVISA). The time was ripe, with great interest on the part of the Ministry of State Administration and Reform (MARE) in introducing the guidelines of the Mas-ter Plan for Public Sector Reform and qualifying some Federal government bodies as executive agencies 1.
Importantly, since the great Administrative Reform under the Getúlio Vargas Administra-tion, strategic policies for economic develop-ment were invariably attributed to autonomous government bodies with the aim of safeguard-ing them from political lobbysafeguard-ing (i.e., so-called bureaucratic insulation), while allowing them more streamlined decision-making and expert staff. Foundations and autarquias were thus created that aimed to intervene directly in eco-nomic relations and balance consumption and production, regulate importation and exporta-tion, and expand the national infrastructure, thereby industrializing the country. The admin-istrative reforms up until the Jânio Quadros Ad-ministration (1961) planned and ordered devel-opment by means of “islands of excellence”, cut out of direct administration for state action in the economy. During Brazil’s military govern-ments, the “administration for development” model focused on state expansion in economic and social life, decentralization of public sector activities, and the creation of indirect adminis-trative organizations for intervention especially in the economy 16.
The regulatory reform carried out by various countries in the 1980s and 1990s and launched by the United States in the 1970s was adopted particularly in Great Britain during the Thatcher Administration 17,18. In Brazil, the National Priva-tization Program (PND) launched in 1991 and expanded from 1995 onward provided the basis for privatization of state-owned companies and the implementation of the Master Plan for Public Sector Reform, which in broad strokes displayed four different sectors: a strategic core (Executive,
Legislative, and Judiciary Branches); exclusive state activities carried out by executive and regu-latory agencies; non-exclusive services, in which the state acted in cooperation with non-state public organizations; and the sector producing goods and services for the market, i.e., the state-owned monopolies subject to privatization 14.
Thus, the proposal for agencies to regu-late activities provided by private parties once again prioritized the creation of technical bod-ies shielded from political lobbying, both to in-tervene in activities linked to economic devel-opment and to protect the interests of services users, thus comprising activities focused on the public interest 19.
In this context, meetings between the Health Surveillance Secretariat, Ministry of Health, and Ministry of State Administration and Reform staff in 1996 resulted in a project for an executive agency called the AGVISA, containing the draft for a Provisional Measure to create an autarquia
(scheduled for December 1996) and a prelimi-nary bill of law with a career plan for AGVISA experts in health surveillance activities. Still, despite the highly critical assessment of the sec-tor, the effort by its managers, and the demands by the principal representatives of the regulated sector, the initiatives for change in the Health Surveillance Secretariat failed to enter the Fed-eral government’s decision-making agenda.
The years 1996 and 1997 were especially turbulent for health in Brazil due to the sector’s severe financial crisis, generating political fric-tion between the Ministers of Health, Econom-ics, and Planning. The main bone of contention lay in the Health Ministry’s proposal to create the so-called Provisional Contribution on Movement or Transfer of Amounts and Financial Credits and Rights (CPMF) 20, fully earmarked for the National Health Fund, as a way of tackling the financial crisis; however, once again, the Finance Ministry suggested that the Health Ministry cut expenditures. The Health Minister’s refusal to do so depleted his bargaining power and led to his resignation in 1996, followed by that of Health Surveillance Secretary Elisaldo Carlini in March 1997. Among a series of motives, the decisive factor was a clash with Argentina over Brazilian health control measures targeting foodstuffs and registration of medicines from that country. In short, based on these events, turning the Health Surveillance Secretariat into an executive agency disappeared from the Ministry of Health’s agenda of priorities 1.
pro-liferating in the mass media (Folha de S. Paulo
database, 1990-200). In June 1998, several batch-es of the contraceptive Microvlar, manufactured by Schering, were found to be inert, leading to unwanted pregnancies in numerous women. Confirmation of the counterfeiting of the drug Androcur, used to treat prostate cancer, led to widespread insecurity as to the quality of drugs. The growing number of outraged press stories showed that drug counterfeiting was on Brazilian society’s agenda, precisely during a Presidential election campaign.
Given the burgeoning demand for answers, Minister Serra took such measures as: sanctions against companies that produced, distributed, and marketed fake or inert medicines; issuing of normative acts; publicizing channels for lodg-ing complaints; and in the Judiciary sphere, the creation of so-called Public Health Precincts to investigate health sector crimes. In addition, responding to the public outcry and media pressure, the National Congress passed Act. 9,677/98 21, altering provisions from Chapter III, Section VIII of the country’s Penal Code, includ-ing the classification of heinous crimes against the public health, and Act 9,695/98 22, altering the classification of crimes related to counter-feiting and tampering with products subject to health surveillance.
The facts and events that came to light in 1998 demonstrate what sociologist Giddens 23 calls the “new moral climate” in political decision-mak-ing, placing governments and inspection agen-cies in a dilemma vis-à-vis risk. First, alarmism is often necessary, but corrosive. Meanwhile, re-luctance to create alarm or to give in to interest groups causes indignation, since in many cases the population cannot (and will not) wait for in-spection agencies to reach an opinion about the levels and types of risk involved in a given situa-tion 19. Given this mismatch, Minister Serra ad-opted a strategy of acknowledging the problems in the Health Surveillance Secretariat, asking for the population’s help in inspection and oversight, and announcing the creation of a new agency to deal with the problems. The President Cardoso meanwhile authorized all necessary measures to guarantee better quality of food and drugs in the country. The creation of a National Health Surveillance Agency became a government pri-ority in the year 1998. Physician and administra-tor Gonzalo Vecina Neto took over as head of the Health Surveillance Secretariat to implement the institutional change 1.
Formulating the change
The factors to be considered in the institutional change thus included the gravity of the situa-tion for the country’s public health, the limited governing capacity of the Health Surveillance Secretariat, especially in the area of medicines, and the need to adapt to the new state regula-tory model and the requirements of international health agreements. Still, these problems had al-ready been identified for some time. What really brought about the change?
As highlighted in the policy analysis litera-ture, a determinant factor for an issue to enter the decision-making agenda and for a decision to actually be reached is the shaping of a favor-able political conjuncture. In this sense, without a doubt the event that precipitated the decision was President Fernando Henrique Cardoso’s need to strengthen his candidacy for reelec-tion by responding to pressure from both public opinion and the business community. Added to this was the stance by Minister Serra, willing to tackle the problem politically by implementing a radical institutional change in the Health Sur-veillance Secretariat. The country had already experienced the creation of the National Elec-tric Energy Agency (Agência Nacional de Ener-gia Elétrica – ANEEL) in 1996 and the National Telecommunications Agency (Agência Nacional de Telecomunicações – ANATEL) in 1997, which were replicated for the National Petroleum Agency (Agência Nacional do Petróleo – ANP) in 1997 and subsequent agencies, in keeping with the specificities, objectives, and characteristics of the interface with society 19.
However, the process involved difficult nego-tiations. It was not the aim of the Ministry of State Administration and Reform, even in the econom-ic area, to turn the Health Surveillance Secretariat into a regulatory agency. Thus far, this expensive but politically powerful model had been designed exclusively for infrastructure areas that the Feder-al Government considered strategic. The turns in the decision-making process were clear: first, the proposal for an executive agency; then a specific regulatory agency for the area of food and drugs; and later, a regulatory agency limited to drugs. In the latter, the proposal involved a streamlined body with a focus on the object of public con-cern at that moment (drugs), either maintaining the other activities within the Health Surveillance Secretariat (which would continue to exist) or de-centralizing them to the States and Municipali-ties, as the Ministry of State Administration and Reform and economic sectors wanted 1.
Surveil-lance Secretariat’s “dependency path” became evident, given the improbability that its histori-cally built field of action would be fragmented. Besides, as indicated by Immergut 2,3, an insti-tution’s structural elements tend to persist and influence its decision-making processes. In other words, while for the Ministry of State Adminis-tration and Reform and the Ministry of Finance the Health Surveillance Secretariat would have to adjust to the design of an executive agency with limited objectives, for the Secretariat itself the is-sue was to maintain and expand its attributions through a regulatory agency. The latter alterna-tive meant autonomy granted by a mandate to the directors, in addition to expanding the scope, range of activity, and staff with respective job po-sitions and pay scales. The choice was whether the response would be narrow, to solve the more pressing problem, or a far-reaching political de-cision, providing Health Surveillance with un-precedented power resources.
Based on the above, there were two oppos-ing concepts clashoppos-ing at the negotiatoppos-ing table, one favoring the “minimal state” and another the “necessary state”, whereby among the existing de-mands, the state selects those it considers crucial for the preservation of the social order, and which thus, as indicated by Przeworski 24, have the type of apparatus that allows the state to do what must be done (and only that). This also meant addi-tional expenditures for the Federal Government and granting characteristics with political power to an institution: financial and administrative autonomy and management stability. The con-troversy dragged on for days until the Ministry of Health sent the draft of a Provisional Measure to the President on December 12, 1998.
On December 30, President Cardoso submit-ted Provisional Measure 1,791/98 to the National Congress, thus launching the policy’s legislative phase.
In Brazil, a Provisional Measure is a powerful lawmaking prerogative of the Executive Branch, which became strategic in the decision-making that was beginning in the National Congress. Recourse to a Provisional Measure rather than submitting a regular bill of law was due to the ur-gency in creating the aur-gency and defining health surveillance taxes to be paid by companies for health control activities (crucial resources for the agency to fund its activities). However, these taxes were not to be approved by a Provisional Measure, but by an ordinary law that would have to be passed by December 30, 1998 (according to Brazil’s fiscal year regime) in order to charge the taxes in 1999. This underlying practical factor determined the entire decision-making process in the Executive and Legislative Branches.
Importantly, during the passage of the Provi-sional Measure and enactment of the law creating ANVISA, President Cardoso had been reelected in the first round of the elections with 53.6% of the votes and enjoyed a broad support coalition in the National Congress. This political dispensa-tion was extremely favorable for approval of the agency without altering structural aspects in its configuration and within the planned timeframe for its implementation.
No amendments were submitted during the regimental timeframe, and no restrictions were received from the Joint Committees on Admis-sibility and Constitutionality and Merit, with a favorable report issued by the rapporteur, Con-gressman Carlos Mosconi (member of the gov-ernment party, PSDB, from the State of Minas Gerais) 25. The parties named the Senators and Representatives that participated in the Special Joint Session on January 13, 1999, to discuss the Provisional Measure. Its speedy passage was due to the prior consensus between the Executive and the various party leaders, i.e., the Executive had the necessary Congressional support, and the Legislative Branch refrained from any move to veto.
Some 60 different lobby groups participated in the Congressional arena. Although the Ex-ecutive had the support it needed in Congress, during this phase any potential veto points or windows of opportunity for filibustering might have prolonged the discussions or even led to impasses, given that this was a strategic moment for the industrial and corporatist lobbies to sway decisions in their favor.
health surveillance in the States and Municipali-ties; expansion of social control mechanisms; drafting and implementation of the generic drugs act; reduction of health surveillance taxes for small domestic companies; reallocation of Health Surveillance Secretariat employees; and preservation of the INCQS at FIOCRUZ. The fol-lowing month, the above-mentioned agreement resulted in Provisional Measure 1.814/99, the first of a series of measures subsequent to the Act and issued during the implementation of ANVS (whose acronym was later changed to ANVISA).
Beginning with the enactment of the legis-lation, the challenge would be the capacity to implement the Agency in keeping with the ob-jectives for which it had been created, because, as highlighted by Diniz 26, although the state in Bra-zil decides, legislates, and regulates to a consider-able degree, historically speaking it has proven powerless to achieve it goals.
Final remarks
In Brazil, the process of institutional change in Health Surveillance at the Federal level in the mid-1990s took place in a context of economic changes in the international arena, accompa-nied at the domestic level by the consolidation of democracy and its institutions, a trend toward economic stabilization, reorganization of politi-cal and social forces, radipoliti-cal restructuring of the Health System, and reform of the state appara-tus.
The process further resulted in a growing mismatch between the intensification of inter-national trade with rapid technological develop-ment and the Health Surveillance Secretariat’s limited capacity to respond to urgent problems that required profound transformations in the regulation of public-private relations, new pa-rameters to provide it with technical, social, and political credibility, and governing capacity over the sectors it was supposed to regulate. No less important for this outcome was the need for the government to transform its own structure vis-à-vis pressure by national and international indus-trial sectors to define stable and predictable legal and technical rules for commercial transactions subject to health control.
The politicization of the health surveillance issue in the 1990s gradually gained space begin-ning in 1995, during the Cardoso Administration. Under Health Minister Jatene, the sector’s strate-gic value was identified, and with it the need for decision-making autonomy, reduction of private interference, an expert technical staff, and regu-latory capacity in keeping with modern technical
standards, requirements that fit the prerogatives conferred by the executive agency model which had recently been introduced in Brazil by the Master Plan for Public Sector Reform.
However, the initiative did not take hold, since it was subsumed by the severe financial crisis that struck the Unified National Health System at that moment, sparking sharp disagreement between the Administration and Minister Jatene. Even despite factors favorable to the change such as the repetition of dramatic problems in healthcare establishments, the insistence of private players on the need for changes in the Health Surveil-lance Secretariat, the coalition in support of the Administration within the National Congress, and the interest by the Ministry of State Adminis-tration and Reform (in addition to international pressure), the situation remained undefined.
However, the situation changed in 1998: the proliferation of exposés on counterfeiting of medicines, the public’s reaction, and the media’s investigative role turned drug quality into a cru-cial national issue to be solved by the authorities, to the extent that it signaled the anachronism of the state’s action, precisely during the Presiden-tial election campaign. Given the accumulated problems, Minister Serra catalyzed the demands for solutions in the Health Surveillance Secre-tariat and became the main political player in the process leading to the creation of ANVISA. In the Executive, this process involved the princi-pal agents and stakeholders in the issue, with the Ministries of Health, Finance, and Public Sector Reform vying for power and influence, while the diverging interests were neutralized during the negotiations to the point of materializing crucial aspects in the transformations proposed by the Health Surveillance Secretariat.
Key to the story was the identification (by the Administration and industrial sectors) of the need for a regulatory agency as the best option to respond technically and politically to the sector’s issues. Thus, for the first time in the country, a format already created for the economy’s strate-gic sectors was transposed to the social area.
Congress did not raise any vetoes to the Ad-ministration’s proposal: on the contrary, there were decisive allies among the parties belonging to the support coalition. This result can be attrib-uted to President Cardoso’s reelection in the first round in October 1998, facilitating the creation of the Agency within the foreseen timeframe.
In conclusion, despite almost a decade of dis-cussions on the need to transform Health
Surveil-lance at the Federal level in Brazil, the institution-al change that included the creation of ANVISA resulted from a specific political conjuncture in 1998-1999, allowing the political, technical, and social actors to introduce a change in the agenda, decide on it, and launch its implementation in an unusually short timeframe. This decision was one of the most important and irreversible mile-stones in the history of public health in Brazil.
Resumo
Este artigo examina o processo de decisão política en-volvido na criação da Agência Nacional de Vigilância Sanitária (ANVISA) em 1999. Primeiro aborda os ante-cedentes da Secretaria de Vigilância Sanitária e a ne-cessidade de sua modernização para adequar a qua-lidade dos produtos sob seu controle às exigências das demandas nacionais e internacionais. Em seguida, sob a perspectiva teórica do neoinstitucionalismo, analisa o contexto sócio-político do debate relativo às alterna-tivas propostas para adequar a Vigilância Sanitária a novas regras congruentes com essas exigências, dando destaque ao processo de formulação da nova política, às arenas de decisão e aos atores com interesses no se-tor. A pesquisa foi realizada com base em farto mate-rial documental e jornalístico, acrescida de entrevistas com atores privilegiados. Conclui-se que na construção da ANVISA foi determinante a favorável conjuntura política nacional ao propiciar a correlação positiva de forças que, em um espaço de tempo em extremo curto (1998-1999) permitiu criar a primeira agência regula-dora na área das políticas sociais no Brasil.
Vigilância Sanitária; Agência Nacional de Vigilância Sanitária; Políticas Públicas
Contributors
References
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Submitted on 08/Aug/2005
